Ecotoxicological risk assessment of chosen pharmaceuticals detected in surface waters.

The goal of this work was to assess the risk posed by the presence of ciprofloxacin, 17α-ethinylestradiol and 5-fluorouracil in aquatic ecosystems based on chronic single-species ecotoxicological tests. There were 23 species used in this study: one cyanobacterium, three green algae, one higher plant, one protozoan, two crustaceans, two fish, 12 bacteria and one fungus (yeast). The risk assessment was performed on the basis of the PEC/PNEC ratio (PEC - predicted environmental concentration, PNEC - predicted no-effect concentration). PNEC was calculated using an assessment factor and statistical extrapolation models. The risk in relation to aquatic organisms proved to be high. The potentially affected fraction of aquatic species in the presence of pharmaceutical active ingredients, depending on the calculation method and the selected concentration in surface waters (predicted or measured), ranged from 6.26 to 27.84% for ciprofloxacin, 2.13 to 18.74% for 17α-ethinylestradiol and 4.96 to 39.28% for 5-fluorouracil. The study indicates several gaps in the existing guidelines, which may be considered within the guideline-revision process.

In vitro and in vivo genotoxicity assessment of selected pharmaceuticals in relation to Escherichia coli and Cyprinus carpio.

Genotoxicity studies (using SOS chromotest and comet assay) of Escherichia coli and carp (Cyprinus carpio) were performed for three pharmaceutically active compounds, ciprofloxacin, 17α-ethinylestradiol and 5-fluorouracil, used in the treatment of humans. The values of genotoxicity induction coefficient (I) in the SOS chromotest clearly showed genotoxicity for ciprofloxacin, both in the presence and in the absence of S9 fraction; 17α-ethinylestradiol demonstrated slight genotoxicity at the highest tested concentration; and 5-fluorouracil did not induce genotoxic effects in Escherichia coli mutants. Statistical analysis of the results of the comet assay revealed significant differences in cell populations derived from carp placed in a solution of 5-fluorouracil in comparison with the negative control. Statistical analysis also showed a significant increase of "% DNA in tail" of comets in cell populations incubated in solutions of 17α-ethinylestradiol at concentrations of 10000, 2000 and 400 µg/L and in solutions of 5-fluorouracil with S9 fraction at concentrations of 50,000 and 2,000 µg/L in comparison with the negative controls.